The Daily Report is a compilation of COVID-19 (coronavirus) news briefs from around the world to help life sciences and health care companies stay current in this challenging time.

In Monday's report: new European Commission Medical Device Coordination Group guidance, U.S. FDA EUAs for a blood purification system and to decontaminate resipirators, and a global litigation update.

Monday, 13 April 2020

• As a result of the COVID-19 outbreak and the associated quarantine and travel restrictions, the ability of notified bodies to conduct mandatory on-site audits under medical devices legislation has been significantly affected. The European Commission's Medical Device Coordination Group (MDCG) has, therefore, prepared a guidance which outlines the temporary extraordinary measures to be followed by notified bodies during the pandemic to permit the continued certification of medical devices and assist in the prevention of potential medical device shortages. The guidance is immediately applicable. Read more here. (Authored by Fabien Roy)

• On 9 April 2020, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) to Terumo BCT Inc. and Marker Therapeutics AG for use of their Spectra Optia Apheresis System with the Depuro D2000 Adsorption Cartridge devices as a blood purification system to treat patients 18 years of age or older with confirmed Coronavirus Disease 2019 (COVID-19) admitted to the intensive care unit (ICU) with confirmed or imminent respiratory failure. The authorized product works by reducing the amount of cytokines and other inflammatory mediators (small active proteins in the bloodstream that control a cell’s immune response) by filtering the blood and returning the filtered blood to the patient. Learn more here. On 9 April, the FDA also granted an EUA to STERIS Corporation for the STERIS V-PRO 1 Plus, maX and maX2 Low Temperature Sterilization Systems using the STERIS N95 Decontamination Cycle (non-lumen cycle), which uses vaporized hydrogen peroxide to decontaminate compatible N95 or N95-equivalent respirators. This EUA is estimated to support decontamination of approximately 750,000 N95 respirators per day in the U.S. Learn more here. (Authored by Ted Wilson)

• The Hogan Lovells litigation team is closely following the impact of COVID-19 on the operation of courts around the world and what this means in practice for clients engaged in or contemplating litigation. Our latest global litigation update, online here, provides critical notices regarding upcoming hearings, deadlines, and limitation periods for the Court of Justice of the European Union (CJEU), as well as courts in China, France, Germany, Italy, Japan, Mexico, the Netherlands, Spain, the UK, and the U.S. (Authored by Katie McConnell)

Daily reports for the week of 6 - 10 April are online here.

Daily reports for the week of 30 March - 3 April are online here.

Daily reports for the week of 23 - 27 March are online here.

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